Enbio Technology Sp. z o. o.
PL-MF-000024063 · Poland · Gdynia
Enbio Technology Sp. z o. o. is registered in the European database on medical devices as a manufacturer, with 22 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 21 |
|---|---|
| Class IIb | 1 |
Most frequent device types declared: Enbio S.
Among these devices, 22 are declared active.
Devices declared under this manufacturer
- Enbio S
Showing 12 of 22 declared devices.
Catalogue references include Enbio PRO, Enbio S, Enbio S (P-EU).
European nomenclature codes declared: Z12011305.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | ENBIO TECHNOLOGY SP. Z.O.O. (PL) · FDA 3018815412 |
| Devices in EUDAMED | 22 |
| Country of registration | Poland |
Device-level evidence
| Devices with a numeric GTIN | 22 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: United States only. Enbio Technology Sp. z o. o. is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
TNP/MDR/0047/4332/2026 | reissued | 2029-02-05 |
TNP/MDR/0007/4332/2023 | issued | 2026-02-05 |